The following data is part of a premarket notification filed by Renovia Inc. with the FDA for Leva Pelvic Floor Trainer.
| Device ID | K180637 |
| 510k Number | K180637 |
| Device Name: | Leva Pelvic Floor Trainer |
| Classification | Perineometer |
| Applicant | Renovia Inc. 263 Summer St., 5th Floor Boston, MA 02210 |
| Contact | Gina Prochillo-cawston |
| Correspondent | Gina Prochillo-cawston Renovia Inc. 263 Summer St., 5th Floor Boston, MA 02210 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-12 |
| Decision Date | 2018-04-04 |